PsoriasisPhase 1NCT05504317
A Study of AK111 in Subjects With Moderate-to-severe Plaque Psoriasis
A Phase 1 study testing AK111 in people with Psoriasis, run by Akeso at 2 sites in China.
Trial summary
This is a Phase Ib clinical study of multiple dose escalation of AK111 in subjects with moderate-to-severe plaque psoriasis Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Psoriasis
- What is being tested?
- AK111
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 2 sitesChina
- Study dates
- 28 May 2020to 2 Mar 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Moderate to severe plaque-type psoriasis diagnosed for at least 6 months;
- Subjects with moderate-to-severe plaque psoriasis at baseline, who were defined as follows: Body Surface Area (BSA) ≥ 10%, PASI ≥ 12 and SPGA score ≥ 3;
- Subjects with a history of systemic therapy or phototherapy for psoriasis at least once before, or suitable to receive systemic therapy or phototherapy for psoriasis assessed by investigator;
- Women of childbearing age is not pregnant or lactating, and the subjects and their partners voluntarily take contraceptive measures considered effective by the investigator during the treatment period and at least 6 months after the last receipt of the study drug.
Who cannot join
- Forms of psoriasis other than chronic plaque-type psoriasis;
- History or evidence of active/latent tuberculosis;
- Positive results of confirmatory serology test for hepatitis B, hepatitis C,HIV or syphilis at screening;
- History of serious infection within 2 months before screening;
- History of malignancy of any organ system;
- Inadequate washout period for prior psoriatic therapy;
- Previous use of secukinumab, ixekizumab or any other drug that targets IL-17 or IL-17 receptor;
- Any medical conditions, in the opinion of the investigator, would place the subject at risk, interfere with study participation or study results interpretation.
Trial locations and contacts
2 sites in 1 country.
China2 sites
AkesoBio Investigative Site 1001
Beijing
AkesoBio Investigative Site 1002
Bengbu, Anhui
About this study
Official title: A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AK111 in Subjects With Moderate-to-severe Plaque Psoriasis
This is a Phase Ib clinical study of multiple dose escalation of AK111 in subjects with moderate-to-severe plaque psoriasis
Read the detailed description
This is a randomized, double-blind, placebo-controlled phase Ib clinical study. This study aims to determine the safety, tolerance, pharmacokinetics(PK) and Pharmacodynamics (PD) characteristics, immunogenicity and preliminary clinical efficacy of multiple dose escalation administration of AK111 in subjects with moderate-to-severe plaque psoriasis..
- Conditions
- Psoriasis
- Being tested
- AK111, Placebo
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AK111Drug
Subjects will receive one of four escalated doses of AK111 (75mg/150mg/300mg/450mg) injection subcutaneously.
PlaceboDrug
Subjects will receive corresponding dose of placebo injection subcutaneously.
| Study group | Role | What they receive |
|---|---|---|
| AK111 regimen | Experimental | Not described Receives: Drug: AK111 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of Safety
Incidence of treatment emergent adverse events (TEAE), serious adverse events (SAE).
Measured: Baseline till Week 20
PK evaluation: T1/2
Assessment of elimination half-life (T1/2) after AK111 administration.
Measured: Baseline till week 20
PK evaluation: AUC
Assessment of area under curve (AUC) after AK111 administration.
Measured: Baseline till week 20
PK evaluation: Cmax
Assessment of maximum plasma concentration (Cmax) after AK111 administration.
Measured: Baseline till week 20
PK evaluation: Tmax
Assessment of time to maximum plasma concentration (Tmax) after AK111 administration.
Measured: Baseline till week 20
Secondary outcomes (5)
PASI 75
Proportion of subjects who achieve Psoriasis Area and Severity Index (PASI) 75 response which means whose PASI score decrease at least 75 percent compared with baseline at week 12.
PASI is a measure of overall psoriasis severity and coverage. The PASI score is in the range of 0 (no psoriasis on the body) to 72 (the most severe case of psoriasis).
Measured: At week 12
PASI 90
Proportion of subjects who achieve PASI 90 response which means whose PASI score decrease at least 90 percent compared with baseline at week 12.
PASI is a measure of overall psoriasis severity and coverage. The PASI score is in the range of 0 (no psoriasis on the body) to 72 (the most severe case of psoriasis).
Measured: At week 12
PASI 100
Proportion of subjects who achieve PASI 100 response which means whose PASI score decrease 100 percent compared with baseline at week 12.
PASI is a measure of overall psoriasis severity and coverage. The PASI score is in the range of 0 (no psoriasis on the body) to 72 (the most severe case of psoriasis).
Measured: At week 12
sPGA 0/1
Proportion of subjects who achieve Static Physicians Global Assessment (sPGA) 0/1 which means whose sPGA score is clear or almost-clear at week 12.
The sPGA is a measure of global assessment of the patient's overall severity, which could be converted to numerals ranging from 0 to 5 (clear = 0, almost-clear = 1, mild = 2, moderate = 3, marked = 4, and severe = 5).
Measured: At week 12
Immunogenicity
Proportion of subjects with detectable anti-drug antibody (ADA).
Measured: Baseline till week 20
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2022
- Study start28 May 2020
- Primary completion2 Mar 2021
- Study completion2 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- More trials run by AkesoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Akeso
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05504317
- Sponsor's protocol ID
- AK111-102
- Status last verified
- Mar 2025
- First submitted
- 29 Jun 2022
- Last updated
- 5 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jiang C, Zhou H, Zhang W, Xia Y, Li B, Ni X, Wang G, Zhang W, Chen B, He Z, Zhang M, Chen R, Jin H, Deng L. Efficacy, Safety and Pharmacokinetics of IL-17 Monoclonal Antibody Injection (AK111) in Patients with Moderate-to-Severe Plaque Psoriasis: A Randomized, Double-Blinded, Placebo-Controlled Phase Ib Multidose Escalation Clinical Study. Dermatol Ther (Heidelb). 2023 Feb;13(2):555-567. doi: 10.1007/s13555-022-00880-1. Epub 2022 Dec 24.
PubMed 36566344
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AK111 in Subjects With Moderate-to-severe Plaque Psoriasis
- ClinicalTrials.gov ID
- NCT05504317
- Acronym / sponsor ID
- AK111-102
- Conditions
- Psoriasis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- AkesoIndustry (pharma, biotech, devices)
- Study start
- 28 May 2020 (actual)
- Primary completion
- 2 Mar 2021 (actual)
- Study completion
- 2 Mar 2021 (actual)
- First posted
- 17 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase Ib clinical study of multiple dose escalation of AK111 in subjects with moderate-to-severe plaque psoriasis
Detailed description
This is a randomized, double-blind, placebo-controlled phase Ib clinical study. This study aims to determine the safety, tolerance, pharmacokinetics(PK) and Pharmacodynamics (PD) characteristics, immunogenicity and preliminary clinical efficacy of multiple dose escalation administration of AK111 in subjects with moderate-to-severe plaque psoriasis..
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AK111 regimen | Experimental | Drug: AK111 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Moderate to severe plaque-type psoriasis diagnosed for at least 6 months;
- Subjects with moderate-to-severe plaque psoriasis at baseline, who were defined as follows: Body Surface Area (BSA) ≥ 10%, PASI ≥ 12 and SPGA score ≥ 3;
- Subjects with a history of systemic therapy or phototherapy for psoriasis at least once before, or suitable to receive systemic therapy or phototherapy for psoriasis assessed by investigator;
- Women of childbearing age is not pregnant or lactating, and the subjects and their partners voluntarily take contraceptive measures considered effective by the investigator during the treatment period and at least 6 months after the last receipt of the study drug.
Key exclusion criteria (8 listed)
- Forms of psoriasis other than chronic plaque-type psoriasis;
- History or evidence of active/latent tuberculosis;
- Positive results of confirmatory serology test for hepatitis B, hepatitis C,HIV or syphilis at screening;
- History of serious infection within 2 months before screening;
- History of malignancy of any organ system;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AK111Subjects will receive one of four escalated doses of AK111 (75mg/150mg/300mg/450mg) injection subcutaneously. | Drug | AK111 regimen |
| PlaceboSubjects will receive corresponding dose of placebo injection subcutaneously. | Drug | Placebo |
Primary outcome
Assessment of Safety
Time frame: Baseline till Week 20
Incidence of treatment emergent adverse events (TEAE), serious adverse events (SAE).
PK evaluation: T1/2
Time frame: Baseline till week 20
Assessment of elimination half-life (T1/2) after AK111 administration.
PK evaluation: AUC
Time frame: Baseline till week 20
Assessment of area under curve (AUC) after AK111 administration.
PK evaluation: Cmax
Time frame: Baseline till week 20
Assessment of maximum plasma concentration (Cmax) after AK111 administration.
PK evaluation: Tmax
Time frame: Baseline till week 20
Assessment of time to maximum plasma concentration (Tmax) after AK111 administration.
5 secondary outcomes
PASI 75
Time frame: At week 12
PASI 90
Time frame: At week 12
PASI 100
Time frame: At week 12
sPGA 0/1
Time frame: At week 12
Immunogenicity
Time frame: Baseline till week 20
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2025.
- Derived from this study: PubMed 36566344Jiang C, Zhou H, Zhang W, Xia Y, Li B, Ni X, Wang G, Zhang W, Chen B, He Z, Zhang M, Chen R, Jin H, Deng L. Efficacy, Safety and Pharmacokinetics of IL-17 Monoclonal Antibody Injection (AK111) in Patients with Moderate-to-Severe Plaque Psoriasis: A Randomized, Double-Blinded, Placebo-Controlled Phase Ib Multidose Escalation Clinical Study. Dermatol Ther (Heidelb). 2023 Feb;13(2):555-567. doi: 10.1007/s13555-022-00880-1. Epub 2022 Dec 24.
- Individual participant dataSharing planned: No
Related trials for Psoriasis
Not yet recruitingPhase 2
Extension Study of Safety and Tolerability of DDY391 in Participants With Moderate to Severe Psoriatic Arthritis (CDDY391A12201-extension)
Moderate to Severe Psoriatic Arthritis
Recruiting
Efficacy of a Self-Management Smartphone App to Improve Safety Skills in Patients With Inflammatory Arthritis
Rhumatoid Arthisis, Spondyloarthritis (SA)
Active, not recruitingPhase 2
Dose Ranging Study of ORKA-001 in Patients With Moderate-to-Severe Plaque Psoriasis
Plaque Psoriasis
RecruitingPhase 1
A Study of HB0017 Injection in Healthy Volunteers to Evaluate Safety and Tolerability of a Single Subcutaneous Injection in Low-Body-Weight Subjects; and Pharmacokinetics at Different Subcutaneous Injection Sites at the Same Dose
Psoriasis, Ankylosing Spondylitis
RecruitingPhase 1
A Study to Learn if Bimekizumab Given in Different Ways is Safe and Moves Similarly Throughout the Body Over Time in Adults
Psoriatic Arthritis, Axial Spondyloarthritis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AK111 in people with Psoriasis, run by Akeso at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of Safety (time frame: Baseline till Week 20). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05504317, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2025.